Seventy-two-year-old Shirley Boles has lost much of her lower jaw to a wasting disease called osteonecrosis. The disease is fairly uncommon, and in Boles’ case, its cause appears to be ironic. Boles, who lives in Fort Walton, Florida (FL), contends she developed osteonecrosis of the jaw, or ONJ, after starting to take Fosamax (alendronate sodium) to stave off the ravages of osteoporosis.
On June 24, 201, a jury agreed with Boles, handing down an $8 million verdict against Merck & Co., the maker of Fosamax. Cases of ONJ have spiked in the 15 years since osteoporosis drugs known generally as bisphosphonates first hit the U.S. market. According to the Associated Press, “Merck faces more than 1,400 lawsuits alleging Fosamax harmed patients.”
Merck has resolutely defended the safety of Fosamax, even as evidence of the drug’s risks for certain patients, and those of similar bone-building medications such as Novartis’ Zometa (zoledronic acid), mount. All prescription and OTC drug carry some risks for more of less serious side effects. But drugmakers have legal and ethical duties to inform patients, prescribers and pharmacists about known risks. When potential side effects become actual, the companies then have duties to issue update side effects warnings and do what they can to aid patients — and their families — who suffered injuries or lost their lives after taking a dangerous drug.
EJL